║่⃭ᛶヨ㦂௦᭰ἲホ౯ሗ࿌᭩2013 ᖺᨵゞ OECD TG 438 ࢽ࣡ࢺࣜࡢ᦬ฟ║⌫ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂㸦ICE ἲ㸸Isolated Chicken Eye Test㸧               

ᖹᡂ 26 ᖺ 9 ᭶ 12 ᪥

JaCVAM ║่⃭ᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍7

JaCVAM ║่⃭ᛶヨ㦂㈨ᩱ⦅⧩ጤဨ఍
ጤဨ㛗      ᑠᆏ ᛅྖ 㸦ṧ␃㎰⸆◊✲ᡤ㸧ጤ ဨ      ⡘ෆ ᱈Ꮚ 㸦ᅜ❧་⸆ရ㣗ရ⾨⏕◊✲ᡤ㸧         ➉ෆ ᑠⱑ 㸦P&G ࢖ࣀ࣮࣋ࢩࣙࣥྜྠ఍♫㸧         ቑ⏣ ග㍤
         ຍ⸨ 㞞୍ 㸦ᰴᘧ఍♫ࢪࣕࣃࣥ㺃ࢸ࢕ࢵࢩ࣭࢚ࣗࣥࢪࢽ࢔ࣜࣥࢢ㸧         ⣽஭ ୍ᘯ 㸦ཧኳ〇⸆ᰴᘧ఍♫㸧         ᒣᮏ ┤ᶞ 㸦⸨⏣ಖ೺⾨⏕኱Ꮫ㸧         ྜྷᮧ ຌ 㸦ᮾி⌮⛉኱Ꮫྡ㄃ᩍᤵ㸧8␎ㄒBCOP:

Bovine Corneal Opacity and Permeability

BRD:

Background Review Document

CM:

Cytosensor Microphysiometer

CV:

Coefficient of Variation

EURL ECVAM: European Union Reference Laboratory for Alternatives to Animal Testing
GHS:

Globally Harmonized System of Classification and Labeling of Chemicals

ICCVAM:

Interagency Coordinating Committee on the Validation of Alternative Methods

ICE:

Isolated Chicken Eye Test

JaCVAM:

Japanese Centre for the Validation of Alternative Methods

NICEATM:NTP Interagency Center for the Evaluation of Alternative Toxicological Methods

OECD:

Organization for Economic Co-operation and Development

SSD:

Streamlined Summary Document

TG:

Test Guideline

UN:United Nations⏝ ㄒࢺࢵࣉࢲ࢘ࣥ᪉ᘧ㸸㔜ᗘࡢ่⃭ᛶࢆṇ☜࡟㆑ู࡛ࡁࡿヨ㦂ἲ࠿ࡽጞࡵࡿホ౯᪉ᘧࠋᮏ࢞࢖ࢻࣛ࢖࡛ࣥࡣࠊ㔜⠜࡞║ࡢᦆയࢆᘬࡁ㉳ࡇࡍ࡜␲ࢃࢀࡿ໬Ꮫ≀㉁࡟㐺⏝ࡉࢀࡿẁ㝵ⓗ࡞ホ౯᪉ᘧࢆᣦࡋࠊࡲࡎࠊ㔜⠜࡞║ࡢᦆയࢆ㉳ࡇࡍ≀㉁ࢆࠊࡑࢀ௨እࡢ≀㉁࠿ࡽṇ☜࡟㆑ู࡛ࡁࡿヨ㦂ἲุู࡛ࡍࡿࡇ࡜࠿ࡽጞࡵࡿ㸦TG438 ANNEX 1,DEFINITIONS㸧ࠋ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ㸸㠀่⃭ᛶࢆṇ☜࡟㆑ู࡛ࡁࡿヨ㦂ἲ࠿ࡽጞࡵࡿホ౯᪉ᘧࠋᮏ࢞࢖ࢻࣛ࢖࡛ࣥࡣࠊ
║่⃭ᛶ࠶ࡿ࠸ࡣ㔜⠜࡞║ࡢയᐖᛶ࡛ࡣ࡞࠸࡜ணࡉࢀࡿ໬Ꮫ≀㉁࡟㐺⏝ࡉࢀࡿẁ㝵ⓗ࡞ホ౯᪉ᘧࢆᣦࡋࠊࡲࡎࠊ║่⃭ᛶ࠶ࡿ࠸ࡣ㔜⠜࡞║ࡢയᐖᛶ࡛ࡣ࡞࠸≀㉁ࢆࠊࡑࢀ௨እࡢ≀㉁࠿ࡽṇ☜࡟㆑ู࡛ࡁࡿヨ㦂ἲุู࡛ࡍࡿࡇ࡜࠿ࡽጞࡵࡿ
㸦TG438 ANNEX 1, DEFINITIONS㸧ࠋ༊ศ1≀㉁:UN (United Nations) GHS (Globally Harmonized Systems of Classification and LabelingofChemicals) ༊ศయ⣔ୗࠊ㔜⠜࡞║ࡢയᐖࢆᘬࡁ㉳ࡇࡍ≀㉁࡜ࡋ࡚༊ศࡉࢀࡿ໬Ꮫ≀㉁༊ศእ≀㉁:UN GHS༊ศయ⣔ୗࠊ║่⃭ᛶ≀㉁࡜ࡋ࡚༊ศࡉࢀ࡞࠸໬Ꮫ≀㉁

9㸯㸬ᨵゞࡢ⫼ᬒࢽ࣡ࢺࣜࡢ᦬ฟ║⌫ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂㸦Isolated Chicken Eye Testࠊ௨ୗ ICE ἲ㸧ࡣࠊ࢘ࢧࢠࢆ⏝࠸ࡓ Draize ║่⃭ᛶヨ㦂ἲ㸦௨ୗࠊDraize ἲ㸧ࡢ௦᭰ヨ㦂ἲ࡛࠶ࡿࠋ2003 ᖺ࠿ࡽ 2006 ᖺ࡟࠿ࡅ࡚ࠊࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ㔜⠜࡞║ࡢയᐖࢆᘬࡁ㉳ࡇࡍ໬Ꮫ≀㉁㸦༊ศ 1 ≀㉁㸧ࢆྠᐃࡍࡿࡓࡵࡢヨ㦂ἲ࡜ࡋ࡚ࠊᅇ㢳ⓗࣂࣜࢹ࣮ࢩࣙࣥࡀ NICEATM (NTP Interagency Center for the Evaluation of AlternativeToxicological Methods) / ICCVAM (Interagency Coordinating Committee on the Validation of AlternativeMethods) ࡟ࡼࡾ࡞ࡉࢀࠊ2009 ᖺ࡟ OECD (Organization for Economic Co-operation and Development) ࢸࢫࢺ࢞࢖ࢻࣛ࢖ࣥ㸦TG: Test Guideline㸧438㸦TG 438, 2009㸧࡜ࡋ࡚᥇ᢥࡉࢀࡓࠋࡇࢀ࡜ࡣู࡟ NICEATM/ICCVAM ࡣ EURL ECVAM (European Union Reference Laboratory forAlternatives to Animal Testing) ࠾ࡼࡧ JaCVAM (Japanese Centre for the Validation of Alternative Methods)ࡢ༠ຊࡢୗࠊ2006 ᖺ࠿ࡽ 2010 ᖺ࡟࠿ࡅ࡚ࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ༊ศእ≀㉁ࡢྠᐃἲ࡜ࡋ࡚ࡢ㐺⏝ᛶ࡟㛵ࡍࡿᅇ㢳ⓗࣂࣜࢹ࣮ࢩࣙࣥࡀ᪂ࡓ࡟⾜ࢃࢀࡓࠋࣂࣜࢹ࣮ࢩࣙࣥ࡟ࡣࠊึᅇ࡟౑⏝ࡉࢀࡓ ICCVAMࢹ࣮ࢱ㸦2006㸧ࡀࡑࡢࡲࡲ⏝࠸ࡽࢀ࡚ゎᯒࡀ࡞ࡉࢀࡓࡀࠊICE ἲࡢᣑ኱㐺⏝ࡢᥦゝ࡟ࡣ⮳ࡽ࡞࠿ࡗࡓࠋ
ࡑࡢᚋࠊ2012 ᖺࠊOECD ᑓ㛛ጤဨ఍࡟ࡼࡾ UN (United Nations) GHS (Globally Harmonized System ofClassification and Labeling of Chemicals) ༊ศୗ࡟࠾࠸࡚෌ホ౯ࡀᐇ᪋ࡉࢀࡓࠋึᅇ࡟౑⏝ࡉࢀࡓࢹ࣮ࢱ࣋
࣮ࢫ࡟࠾ࡅࡿ in vivo ࠾ࡼࡧ in vitro ୧᪉ࡢࢹ࣮ࢱࡀぢ┤ࡉࢀࡓ࡯࠿ࠊin vitro ࡢ༊ศእᇶ‽ࡀṇᘧ࡟タᐃࡉࢀࡓࠋࡑࡇ࡛ᨵࡵ࡚ホ౯ࡀ⾜ࢃࢀࡓ⤖ᯝࠊICE ἲࡣࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ༊ศ 1 ≀㉁ࡢྠᐃࡢࡳ࡞
ࡽࡎࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ༊ศእ≀㉁ࡢྠᐃἲ࡜ࡋ࡚౑⏝ࡍࡿࡇ࡜ࡀྍ⬟࡛࠶ࡿ࡜ุ᩿ࡉࢀࠊ2013ᖺ 7 ᭶ 26 ᪥௜ࡅ࡛ᨵゞ TG438 (TG 438, 2013) ࡜ࡋ࡚᥇ᢥࡉࢀࡓࠋTG 438㸦2013㸧ࡢ୺࡞ᨵゞⅬࡣࠊ1) ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟ࡼࡿ UN GHS ༊ศእ≀㉁ྠᐃ࡬ࡢ㐺⏝࠾ࡼࡧ2) 㐺⏝㝈⏺࡛࠶ࡿࠋᮏ㈨ᩱ⦅⧩ጤဨ఍ࡣࠊࡇࡢ TG 438㸦2013㸧ࡢᨵゞⅬ࡟ࡘ࠸᳨࡚ウࡋࡓࠋ௨ୗ࡟ࡑࡢ⤖ᯝࢆሗ࿌ࡍࡿࠋ㸰㸬ヨ㦂ࡢᴫせICE ἲ࡛ࡣࠊࢽ࣡ࢺࣜ࠿ࡽ᦬ฟࡋࡓ║⌫࡟⿕㦂≀㉁ࢆᭀ㟢ࡋࠊࡑࡢ⤖ᯝࠊ║⌫࡟⏕ࡌࡿゅ⭷ࡢኚᛶࢆࠊ
ゅ⭷ࡢ⭘⬽ࠊΰ⃮ᗘ࠾ࡼࡧࣇࣝ࢜ࣞࢭ࢖ࣥᰁⰍᛶࡢኚ໬࡜ࡋ࡚࡜ࡽ࠼ࡿࠋࡇࢀࡽ 3 ホ౯㡯┠ࡢኚ໬ࢆࡑࢀࡒࢀಶูࡢࢫࢥ࢔࡟ኚ᥮ࡋ࡚ᚓࡽࢀࡿ⥲ྜホ౯ࢆࡶ࡜࡟ in vivo ࡛ࡢ║่⃭ᛶࢆணࡍࡿࠋྛホ౯㡯┠ࡢኚ໬࡜ࡋ࡚ࡣࠊA) ゅ⭷ࡢ⭘⬽㸦ගᏛⓗཌᗘィࢆ⿦╔ࡋࡓ⣽㝽ⅉ㢧ᚤ㙾࡟࡚ゅ⭷ࡢཌࡉࢆᐃࡋ࡚ᭀ㟢 240 ศᚋࡲ࡛ࡢ⤒᫬ⓗ࡞ኚ໬⋡ࢆᐃ㔞ⓗ࡟ồࡵࡿ㸧ࠊB) ゅ⭷ࡢΰ⃮ᗘ㸦⣽㝽ⅉ㢧ᚤ㙾࡟࡚ゅ⭷ΰ⃮ᗘࡢ⤒᫬ⓗ࡞ኚ໬ࢆᭀ㟢 240 ศᚋࡲ࡛ほᐹࡍࡿ㸧ࠊC) ࣇࣝ࢜ࣞࢭ࢖ࣥᰁⰍᛶ㸦⣽㝽ⅉ㢧ᚤ㙾࡟࡚ᭀ㟢 30 ศᚋࡢゅ⭷⾲㠃ࡢࣇࣝ࢜ࣞࢭ࢖ࣥᰁⰍᛶ㸧ࢆᐃࡍࡿࡇ࡜࡛࠶ࡿࠋྛ㡯┠ࡢ⤖ᯝࢆയᐖࡢ⛬ᗘ࡟ࡼࡾࠊ║่⃭ᛶࡢ᭱ࡶᙅ࠸ࢡࣛࢫ I ࠿ࡽ᭱ࡶᙉ࠸ࢡࣛࢫ IV ࡢ 4 ẁ㝵࡟ศ㢮ࡋࠊࡑࢀࡽࡢศ㢮⤖ᯝࢆ⥲ྜࡋ࡚ࠊ⿕㦂≀㉁ࡢ║่⃭ᛶࢆุᐃࡍࡿࠋ㸱㸬ᨵゞⅬ㸱Ѹ㸯㸬In vivo – in vitro ࢹ࣮ࢱ࣮࣋ࢫࡢぢ┤ࡋ TG 438 㸦2013㸧ࡢᨵゞ࡟ඛ❧ࡕ OECD ᑓ㛛ጤဨ఍࡟ࡼࡾࠊ๓ᅇホ౯ࢆ⾜ࡗࡓ ICCVAM (2006)ࣂࣜࢹ
࣮ࢩࣙࣥࢹ࣮ࢱ࣮࣋ࢫࢆࡶ࡜࡟ࡲ࡜ࡵࡽࢀࡓ SSD (Streamlined Summary Document), Appendix 1 (OECD,102013) ࠿ࡽ㔜」ࡍࡿ 3 ≀㉁ࢆ㝖እࡋࡓ 175 ≀㉁࡟ࡘ࠸࡚ࠊin vivo ࠾ࡼࡧ in vitro ࡢಶࠎࡢࢹ࣮ࢱ࡟ࡘ࠸࡚෌ホ౯ࡉࢀࡓࠋIn vivo ࢹ࣮ࢱ࡟ࡘ࠸࡚ࡣࠊ⏕ࢹ࣮ࢱࡀḞዴࡋ࡚࠸ࡿ 15 ≀㉁ࢆᑐ㇟࠿ࡽ㝖እࡋࠊࡉࡽ࡟ಶࠎࡢࢹ࣮ࢱࢆぢ┤ࡍࡇ࡜࡟ࡼࡾ UN GHS ༊ศ࡛ࡢ෌ุᐃࡀ࡞ࡉࢀࡓࠋࡲࡓࠊin vitro ࢹ࣮ࢱ࡛ࡣࢹ࣮ࢱࡢぢ┤ࡋ࡜᪂ࡓ࡟タᐃࡋࡓ UN GHS ༊ศ㸦㸱í㸰í㸯㡯㸧࡟ᇶ࡙ࡃ෌ุᐃࡀ࡞ࡉࢀࡓࠋ௨ୖࡢ෌ホ౯࡟࠾࠸࡚ࠊ
᭱⤊ⓗ࡟࣎ࢺ࣒࢔ࢵࣉ᪉ᘧࡢホ౯࡟ࡣ 175 ≀㉁୰ 152 ≀㉁㸦༢୍≀㉁㸸72ࠊΰྜ≀㉁㸸80㸧ࡀࠊࢺࢵࣉࢲ࢘ࣥ᪉ᘧࡢホ౯࡟ࡣ 140 ≀㉁㸦༢୍≀㉁㸸65ࠊΰྜ≀㉁㸸75㸧ࡀ⏝࠸ࡽࢀࡓࠋ
㸱í㸰㸬࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡛ࡢ UN GHS ༊ศእ≀㉁ྠᐃ࡬ࡢ㐺⏝㸱í㸰í㸯㸬 UN GHS ༊ศእ≀㉁ホ౯ࡢ᪂ࡓ࡞ุᐃᇶ‽ࡢタᐃ
 TG 438 (2013)࡛ࡣࠊ᪂ࡓ࡞࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟ࡼࡿ UN GHS ༊ศእ≀㉁ࡢྠᐃ࡟ᑐᛂࡍࡿࡓࡵࠊ༊ศእ≀㉁ホ౯ࡢࡓࡵࡢุᐃᇶ‽ࡀ᪂ࡓ࡟タᐃࡉࢀࡓࠋ㏣ຍࡉࢀࡓุᐃᇶ‽ࢆ⾲ 1 ࡟♧ࡍࠋ    ⾲ 1㸬 UN GHS ༊ศእ≀㉁ホ౯ࡢࡓࡵࡢุᐃᇶ‽UN GHS ༊ศ3 ホ౯㡯┠ࡢ⤌ࡳྜࢃࡏ㸨༊ศእ

3 㡯┠࡜ࡶࢡࣛࢫ I ࡟ศ㢮ࡉࢀࡿ
2 㡯┠ࡀࢡࣛࢫ I ࡟ศ㢮ࡉࢀࠊ1 㡯┠ࡀࢡࣛࢫ II ࡟ศ㢮ࡉࢀࡿ   㸨㸧3 ホ౯㡯┠㸸ゅ⭷ࡢ⭘⬽ࠊゅ⭷ΰ⃮ࠊゅ⭷ࡢࣇࣝ࢜ࣞࢭ࢖ࣥᰁⰍᛶ      ࢡࣛࢫ I㸸᭱ࡶᙅ࠸║่⃭ᛶ㸱í㸰í㸰㸬࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡛ࡢṇ☜ᛶ ୖグࡢࡼ࠺࡟ホ౯ࡋࡓ᪂ࡓ࡞ࢹ࣮ࢱ࣮࣋ࢫࢆ⏝࠸ࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ༊ศእ≀㉁ࢆྠᐃࡍࡿ
ሙྜࡢṇ☜ᛶ࡟ࡘ࠸࡚ホ౯ࡉࢀࡓࠋ⤖ᯝࢆ⾲ 2 ࡟♧ࡍࠋ ༊ศእ≀㉁ࡢྠᐃ࡟࠾࠸࡚ࠊDraize ἲࡢ⤖ᯝ࡜ẚ㍑ࡍࡿ࡜ࠊICE ἲࡢṇ☜ᗘࡣ 82㸣㸦125/152㸧ࠊឤᗘ99㸣 㸦72/73㸧ࠊ≉␗ᗘࡣ 67㸣㸦53/79㸧ࠊഇ㝜ᛶ⋡ࡣ 1㸣㸦1/73㸧࠾ࡼࡧഇ㝧ᛶ⋡ࡣ 33㸣㸦26/79㸧ࢆ♧ࡋࡓࠋഇ㝜ᛶ⋡ࡣపࡃࠊഇ㝜ᛶࢆ♧ࡋࡓ≀㉁ࡣ㜵ở᭷ᶵ⁐፹ྵ᭷ሬᩱ 3 ≀㉁୰ 1 ≀㉁㸦TNO-94㸧ࡢࡳ࡛࠶ࡗࡓࠋ୍᪉ࠊഇ㝧ᛶ⋡ࡣ㧗࠸ࡀࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡛ࡣ㝧ᛶ⤖ᯝࡀᚓࡽࢀࡓሙྜࠊ௚ࡢ㐺ษ࡞ヨ㦂ἲ࡟ࡼࡿ☜ㄆࡀᚲせ࡜ࡉࢀ࡚࠸ࡿࠋ
⾲ 2㸬࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ ICE ἲࡢṇ☜ᛶ㸫UN GHS ༊ศἲ࡛ࡢ༊ศእ≀㉁ࡢྠᐃ 1࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ

No.

୍⮴ᗘ㸣No.

ឤᗘ㸣
No.

ഇ㝜ᛶ⋡
㸣 No.

≉␗ᗘ㸣
No.

ഇ㝧ᛶ⋡㸣
No.

⿕㦂≀㉁

152

82

125/152

99

72/73

11/73

67

53/79

3326/79㜵ở᭷ᶵ⁐፹
ྵ᭷ሬᩱࢆ㝖እ
ࡋࡓሙྜ

149

83

123/149

100

71/71

00/71

67

52/78

33

26/78

No. = ⿕㦂≀㉁ᩘ 
1

UN GHS ༊ศ: (༊ศእ≀㉁) ᑐ (༊ศእ≀㉁௨እ)

11



㸱í㸰í㸱㸬 ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ᪋タෆ࣭᪋タ㛫෌⌧ᛶ➨୕⪅ホ౯ሗ࿌᭩㸦➨୕⪅ホ౯ሗ࿌᭩ 2012ࠊICCVAM BRD : Background Review Document 2006㸧࡛ሗ࿌ࡉࢀ࡚࠸ࡿ࡜࠾ࡾࠊICE ἲࡢゅ⭷⭘⬽ࢆᣦᶆ࡜ࡋࡓሙྜࡢ᪋タෆ CV ್ࡣ 1.8㸣ࠥ6.3㸣࡛࠶ࡗࡓࠋ ⿕㦂≀㉁ࡢ࠺ࡕࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࠾ࡼࡧࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡜ࡶࠊ඲࡚ࡢ᪋タ࡟࠾࠸࡚ UN GHS ༊ศࡀ୍⮴ࡋࡓ⿕㦂≀㉁ࡣ 75㸣ࢆ༨ࡵࡓࠋࡲࡓࠊUN GHS ༊ศ࡜ࡢ୍⮴ࢆᣦᶆ࡜ࡋࡓሙྜࠊ୺ᑟ᪋タ࡜௚ࡢཧຍ᪋タ࡜ࡢ㛫ࡢ┦㛵ಀᩘࡣ 0.829ࠥ0.849 ࡛࠶ࡗࡓࠋ㸱í㸱㸬ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡛ࡢ UN GHS ༊ศ㸯≀㉁ྠᐃ࡬ࡢ㐺⏝㸱í㸱í㸯㸬ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡛ࡢṇ☜ᛶ ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ༊ศ 1 ≀㉁ࢆྠᐃࡍࡿሙྜࡢṇ☜ᛶ࡟ࡘ࠸࡚ࠊ᪂ࡓ࡞ࢹ࣮ࢱ࣮࣋ࢫࢆ⏝࠸࡚ホ౯ࡉࢀࡓࠋ⤖ᯝࢆ⾲ 3 ࡟♧ࡍࠋ ༊ศ 1 ≀㉁ࡢྠᐃ࡟࠾࠸࡚ Draize ἲࡢ⤖ᯝ࡜ẚ㍑ࡍࡿ࡜୍⮴ᗘࡣ 86㸣㸦120/140㸧ࠊഇ㝜ᛶ⋡ࡣ 48㸣
㸦13/27㸧ࠊഇ㝧ᛶ⋡ࡣ 6㸣㸦7/113㸧࡛࠶ࡗࡓࠋ࢔ࣝࢥ࣮ࣝࠊᅛయ࠾ࡼࡧ⏺㠃άᛶ๣ࢆ㝖እࡋࡓሙྜࠊ୍
⮴ᗘࡣୖࡀࡾഇ㝜ᛶ⋡࡜ഇ㝧ᛶ⋡ࡣపୗࡋࡓࠋ
⾲ 3㸬ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ ICE ἲࡢṇ☜ᛶ㸫UN GHS ༊ศ 1 ≀㉁ࡢྠᐃ 1ࢺࢵࣉࢲ࢘ࣥ
᪉ᘧNo.

⿕㦂≀㉁࢔ࣝࢥ࣮ࣝࠊᅛయ࠾ࡼࡧ⏺㠃άᛶ๣ࢆ㝖እ
ࡋࡓሙྜ

୍⮴ᗘ

ឤᗘ

ഇ㝜ᛶ⋡

≉␗ᗘ

㸣

No.

㸣

No.

㸣

No.

㸣

140

86

120/140

52

14/27

48

13/27

82

94

77/82

71

5/7

292/7

No.

ഇ㝧ᛶ⋡
㸣

No.

94 106/113

67/113

96

4

3/75

72/75

No. = ⿕㦂≀㉁ᩘ
1UN GHS ༊ศ: (༊ศ 1 ≀㉁) ᑐ (༊ศ 1 ≀㉁௨እ)㸱í㸱í㸰㸬 ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ᪋タෆ࣭᪋タ㛫෌⌧ᛶ ➨୕⪅ホ౯ሗ࿌᭩㸦➨୕⪅ホ౯ሗ࿌᭩ 2012ࠊICCVAM BRD 2006㸧࡛ሗ࿌ࡉࢀ࡚࠸ࡿ࡜࠾ࡾࠊࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ᪋タෆ࣭᪋タ㛫෌⌧ᛶࡣ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡜ྠᵝ࡞⤖ᯝࡀᚓࡽࢀ࡚࠸ࡿࠋ㸱í㸲㸬㐺⏝㝈⏺
 㜵ở᭷ᶵ⁐፹ྵ᭷ሬᩱࠊᅛయ≀㉁ࠊ⏺㠃άᛶ๣࠾ࡼࡧ࢔ࣝࢥ࣮ࣝ㢮࡟ࡘ࠸࡚ࡣࠊ㧗࠸ഇ㝜ᛶ⋡࠶ࡿ࠸ࡣഇ㝧ᛶ⋡ࡀ♧ࡉࢀࡓࡀࠊ௨ୗࡢ⌮⏤࠿ࡽࡇࢀࡽࡢ໬Ꮫ≀㉁࡟ࡶ ICE ἲࢆ㐺⏝ࡍࡿࡇ࡜ࡀ࡛ࡁࡿ࡜ሗ࿌ࡉࢀࡓࠋ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ㸸y㜵ở᭷ᶵ⁐፹ྵ᭷ሬᩱ࡛㝧ᛶ 2 ≀㉁ࡢ࠺ࡕࠊ1 ≀㉁㸦TNO-94㸧ࡀഇ㝜ᛶ࡛࠶ࡾࠊ⏝㏵ࡢ㢮ఝࡋࡓ໬ྜ≀㸦TNO-93㸧࡟ࡣㄆࡵࡽࢀ࡞࠿ࡗࡓࠋᚑࡗ࡚ࠊICE ἲ࡬ࡢ㐺⏝㡿ᇦ࠿ࡽ㝖እࡍࡿ࡟ࡣ᰿ᣐࡀ୙
12༑ศ࡛࠶ࡾࠊ㜵ở᭷ᶵ⁐፹ྵ᭷ሬᩱࢆ㐺⏝㡿ᇦ࠿ࡽ㝖እࡍࡿᚲせࡣ࡞࠸࡜ࡉࢀࡓࠋy༢୍≀㉁ࠊΰྜ≀㉁ࠊᾮయࠊᅛయ➼࡟࠾ࡅࡿഇ㝜ᛶ⋡ࡣ 5㸣௨ୗ࡜పࡃࠊഇ㝧ᛶ⋡࡟ࡘ࠸࡚ࡣ 33㸣࡜௚ࡢヨ㦂ἲ㸦BCOP: Bovine Corneal Opacity and Permeability㸹 69㸣ࠊCM : Cytosensor
Microphysiometer㸹68㸣㸧࡟ẚ࡭ప࠸ࡇ࡜ࡀ♧ࡉࢀࡓࠋ༢୍≀㉁࠾ࡼࡧ⏺㠃άᛶ๣࡟ࡘ࠸࡚ࡢഇ㝧ᛶ⋡ࡣ㧗࠸ࡀࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾࠸࡚ࡣ㝧ᛶ࡜ุ᩿ࡉࢀࡓሙྜࠊ௚ࡢ㐺ษ࡞ヨ㦂ἲ࡟ࡼࡿ☜ㄆࡀᚲせ࡜ࡉࢀ࡚࠸ࡿࡇ࡜࠿ࡽࠊࡇࢀࡽࡢ໬Ꮫ≀㉁ࢆ㐺⏝㡿ᇦ࠿ࡽ㝖እࡍࡿᚲせࡣ࡞࠸࡜ࡉࢀࡓࠋࢺࢵࣉࢲ࢘ࣥ᪉ᘧ㸸yഇ㝜ᛶ⋡ࡣᅛయ≀㉁㸦n=34, 55㸣=6/11㸧࠾ࡼࡧ⏺㠃άᛶ๣㸦n=21, 67㸣=6/9㸧࡟࠾࠸࡚㧗ࡃࠊഇ㝧ᛶ⋡ࡣ࢔ࣝࢥ࣮ࣝ㢮㸦n=12, 0㸣=4/10㸧࡟࠾࠸࡚㧗࠿ࡗࡓࠋࡋ࠿ࡋࠊࡇࢀࡽࡢศ㢮࡟࠾࠸࡚ࡶ║่⃭ᛶࡀṇ☜࡟ணࡉࢀࡓ≀㉁ࡀ࠶ࡿࡇ࡜ࠊࡉࡽ࡟ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾࠸࡚㝜ᛶ࡜ุ᩿ࡉࢀࡓሙྜࡣ௚ࡢ㐺ษ࡞ヨ㦂ἲ࡟ࡼࡿ☜ㄆࡀᚲせ࡜ࡉࢀ࡚࠸ࡿࡇ࡜࠿ࡽࠊᅛయ≀㉁࠾ࡼࡧ⏺㠃άᛶ๣ࢆ㐺⏝㡿ᇦ࠿ࡽ㝖እࡍࡿᚲせࡣ࡞࠸࡜ࡉࢀࡓࠋࡓࡔࡋࠊ࢔ࣝࢥ࣮ࣝ㢮࡛㝧ᛶ⤖ᯝࡀᚓࡽࢀࡓሙྜࡣࠊ⤖ᯝࡢゎ㔘ࡣៅ㔜࡟ࡍ࡭ࡁ࡜ࡉࢀࡓࠋ ௨ୖ࠿ࡽࠊICE ἲࡣ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡛ࡢ༊ศእ≀㉁࠾ࡼࡧࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡛ࡢ༊ศ 1 ≀㉁ࡢྠᐃἲ
࡜ࡋ࡚ࠊࡍ࡭࡚ࡢ✀㢮ࡢ໬Ꮫ≀㉁࡟㐺⏝࡛ࡁࡿ࡜ࡉࢀࡓࠋ㸱í㸳㸬ࡑࡢ௚y⩦⇍ᗘ☜ㄆ≀㉁ࡢ㏣ຍ㸸  TG 438㸦2009㸧࡛ࡣࠊICE ἲࡢ⩦⇍ᗘࢳ࢙ࢵࢡ⏝≀㉁࡜ࡋ࡚ 10 ≀㉁ࡀ᥎ዡࡉࢀࡓࠋࡋ࠿ࡋࠊ10 ᥎ዡ≀㉁ࡢ୰࡟ࠊ༊ศእ≀㉁ࡀྵࡲࢀ࡚࠸࡞࠿ࡗࡓࡇ࡜࠿ࡽࠊᮏᨵゞ∧࡛ࡣࠊ3 ✀㢮ࡢ༊ศእ≀㉁ࡀ
㏣ຍࡉࢀࠊ௨ୗࡢࡼ࠺࡞⩦⇍ᗘ☜ㄆ≀㉁࡜ࡋ࡚ࡲ࡜ࡵࡽࢀࡓ㸦⾲ 4㸧ࠋᗘ㸧࡜ࡋ࡚“18Υ࠿ࡽ 25Υ”ࡢy║⌫ࡢ㐠ᦙy⿕㦂≀㉁ᭀ㟢ᚋࡢ║⌫Ὑί࡟࠾࠸࡚ࠊ“㏣ຍࡢὙί”ࡀㄆࡵࡽࢀࡓࠋyሗ࿌᭩࡬ࡢグ㍕㡯┠ࡀ㏣ຍࡉࢀࡓࠋyㄒྃࡢᐃ⩏࡟ࡘ࠸࡚㏣ຍ࣭ゞṇࡀ࡞ࡉࢀࡓࠋ

yICE ἲุᐃ࡟㛵ࡍࡿ⏝ㄒ࡜ࡋ࡚ࠊ࢝ࢸࢦ࣮ࣜࡀࢡࣛࢫ࡜࠸࠺⏝ㄒ࡟⨨ࡁ᥮ࢃࡗࡓࠋᗘ㸦እ⏺

ᗘ⠊ᅖࡀ♧ࡉࢀࡓࠋ
13⾲ 4㸬ICE ἲࡢ⩦⇍ᗘ☜ㄆ≀㉁໬Ꮫ≀㉁CAS␒ྕሷ໬࣋ࣥࢨࣝࢥࢽ࢘㸦5㸣㸧
8001-54-5
Benzalkonium chloride (5㸣)ࢡࣟࣝ࣊࢟ࢩࢪࣥ
Chlorhexidine

55-56-1ࢪ࣋ࣥࢰ࢖ࣝ-L-㓇▼㓟
Dibenzoyl-L- tartaric acid2743-38-6

࢖࣑ࢲࢰ࣮ࣝ
Imidazole288-32-4

ࢺࣜࢡࣟࣟ㓑㓟㸦30㸣㸧

ศ㢮
࢜ࢽ࣒࢘
໬ྜ≀㢮
Onium
compound࢔࣑ࣥ㢮࢔࣑ࢪࣥ㢮Amine, Amidine࢝ࣝ࣎ࣥ㓟㢮࢚ࢫࢸࣝ㢮
Carboxylic acid,Ester࣊ࢸࣟࢧ࢖ࢡࣜࢵࢡ໬ྜ≀㢮Heterocyclic≀⌮ⓗ≧ែ

In vivo࡛ࡢ༊ศICE࡛ࡢ༊ศ

ᾮయLiquid༊ศ1Category 1

༊ศ1Category 1

ᅛయ
Solid

༊ศ1
Category 1

༊ศ1Category 1

ᅛయ
Solid

༊ศ1
Category 1༊ศ1Category 1

ᅛయ
Solid

༊ศ1
Category 1

༊ศ1Category 1

76-03-9࢝ࣝ࣎ࣥ㓟㢮
Carboxylic acidᾮయLiquid༊ศ1Category 1

༊ศ1Category 12,6-ࢪࢡࣟࣟ࣋ࣥࢰ࢖ࣝ
ࢡࣟࣜࢻDichlorobenzoyl chloride

4659-45-4

࢔ࢩࣝ
ࣁࣛ࢖ࢻ㢮
Acyl halideᾮయLiquid༊ศ2ACategory 2A༊ศ୙ྍ◪㓟࢔ࣥࣔࢽ࣒࢘
Ammonium nitrate

6484-52-2

ᅛయ
Solid

༊ศ2B
Category 2B༊ศ୙ྍ࢚ࢳࣝ-2-࣓ࢳࣝ࢔ࢭࢺ㓑㓟
Ethyl-2-methylacetoacetate609-14-3

ᾮయLiquid༊ศ2B
Category 2B༊ศ୙ྍࢪ࣓ࢳࣝࢫࣝ࣍࢟ࢩࢻ
Dimethyl sulfoxide

67-68-5↓ᶵሷ
Inorganic saltࢣࢺࣥ㢮࢚ࢫࢸࣝ㢮
Ketone, Ester᭷ᶵ◲㯤໬ྜ≀Organic sulphurcompoundᾮయ
Liquid༊ศእNot Classified༊ศእ
Not Classifiedࢢࣜࢭ࣮ࣟࣝGlycerol

56-81-5࢔ࣝࢥ࣮ࣝ㢮
AlcoholᾮయLiquid༊ศእNot Classified༊ศእ
Not Classifiedᾮయ
Liquid༊ศእNot Classified༊ศእ
Not Classifiedᾮయ
Liquid༊ศእNot Classified༊ศእ
Not Classifiedᾮయ
Liquid༊ศእNot Classified༊ศእ
Not Classified

Trichloroacetic acid (30㸣)࣓ࢳࣝࢩࢡࣟ࣌ࣥࢱࣥ
Methylcyclopentane

96-37-7n-࣊࢟ࢧࣥ
n-Hexane

110-54-3

ࢺࣜ࢔ࢭࢳࣥ
Triacetin102-76-1

Ⅳ໬Ỉ⣲㸦⎔≧㸧Hydrocarbon(cyclo)
Ⅳ໬Ỉ⣲
㸦㙐≧㸧
Hydrocarbon(acylic)⬡㉁
Lipid
14㸲㸬⤖ㄽ TG 438㸦2013㸧࡛ࡣࠊࡑࡢṇ☜ᛶ࡜෌⌧ᛶࡢ⤖ᯝ࠿ࡽࠊUN GHS ࡢ║่⃭ᛶ༊ศ࡟࠾࠸࡚ࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ༊ศ 1 ≀㉁ࡢྠᐃࡢࡳ࡞ࡽࡎࠊ࣎ࢺ࣒࢔ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ༊ศእ≀㉁ࡢྠᐃ࡟ ICE ἲࢆ㐺⏝ࡍࡿࡇ࡜ࡣྍ⬟࡛࠶ࡾࠊ࡝ࡕࡽࡢ᪉ᘧ࡟࠾࠸࡚ࡶ㐺⏝≀㉁࡟ไ㝈ࢆタࡅࡿᚲせࡣ࡞࠸࡜ࡉࢀ࡚࠸ࡿࠋ║่⃭ᛶ㈨ᩱ⦅⧩ጤဨ఍࡜ࡋ࡚ࡶࠊࢺࢵࣉࢲ࢘ࣥ᪉ᘧ࡟࠾ࡅࡿ UN GHS ༊ศ 1 ≀㉁࡞ࡽࡧ࡟࣎ࢺ࣒࢔
ࢵࣉ᪉ᘧ࡟࠾ࡅࡿ UN GHS ༊ศእ≀㉁ࡢྠᐃ࡟ࠊDraize ἲࡢ௦᭰ヨ㦂ἲ࡜ࡋ࡚ TG 438㸦2013㸧ࢆ㐺⏝ࡍࡿࡇ࡜ࡣྍ⬟࡛࠶ࡿ࡜⪃࠼ࡓࠋཧ⪃ᩥ⊩
㸯㸧OECD Guidelines for The Testing of Chemicals, Isolated Chicken Eye Test Method for     Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring     Classification for EyeIrritation or Serious Eye Damage, TG438 (Adopted 26 July 2013)
㸰㸧OECD Guidelines for The Testing of Chemicals, Isolated Chicken Eye Test for Identifying OcularCorrosives and Severe Irritants, TG438 (Adopted 7 September 2009)
㸱㸧Streamlined Summary Document Supporting OECD Test Guideline 438 on the Isolated Chicken Eye for Eye
Irritation/Corrosion. Series on Testing and Assessment No. 188 (Part 1 and Part 2), OECD, Paris. (21 June2013)
㸲㸧ICCVAM, Background Review Document: Current Status of In Vitro Test Methods for Identifying OcularCorrosives and Severe Irritants: Isolated Chicken Eye Test Methods. NIH Publication No. 06-4513 (2006).
㸳㸧ICCVAM, ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods
Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products. NIH Publication No.
10-7553. Volume 1 and Volume 2 (2010).
㸴㸧JaCVAM, ║่⃭ᛶヨ㦂௦᭰ἲࡢ➨୕⪅ホ౯ሗ࿌᭩̺ホ౯ᑐ㇟ヨ㦂㸸║࡟ᑐࡍࡿ⭉㣗ᛶ࠾ࡼࡧᙉ่⃭ᛶホ౯ࡢࡓࡵࡢࢽ࣡ࢺࣜ᦬ฟ║⌫ࢆ⏝࠸ࡓ║่⃭ᛶヨ㦂ἲ, AATEX-JaCVAM J1, 16-29 (2012)15